Monthly Archives June 2021

Episode 3: Should we believe published scientific research?

first_img This lack of reproducibility in science is an open source of consternation in the pharmaceutical industry, where many people feel they can no longer rely on basic findings from academia. Researchers at Bayer and other drug companies have reported dismal success rates trying to reproduce studies in cancer, women’s health, and cardiovascular disease — in some cases as low as 11 percent.advertisement Tags fraudreproducibilityresearch A lot of science isn’t groundbreaking, and that’s a good thing Co-host “The Readout LOUD,” CNBC senior health and science reporter For biotech venture capitalist Bruce Booth, that terrible success rate makes placing a bet on a new scientific discovery an incredibly risky investment. That’s why he spends hundreds of thousands of dollars double-checking the science for reproducibility upfront, and takes his time before pressing his foot on the gas in drug development. Even if that means getting beaten to the punch by another investor. “There are a lot of great ideas in science,” says Booth. “And so if we miss a few great ideas early on but in general reduce our false positive rates, I’d say that is a recipe for very attractive venture returns.”advertisement By Luke Timmerman and Meg Tirrell Dec. 3, 2015 Reprints Isaac Newton famously said that “If I have seen further, it is by standing on the shoulders of giants.” It’s a crucial point. Scientists discover new things by building on facts established by those who came before.But what if the science that laid the groundwork for new discoveries … was wrong? In this week’s episode, we explore what some have come to call the “crisis of reproducibility” plaguing the world of scientific research. Way more than you’d expect, scientific papers that were once presented as fact are taken back. The blog Retraction Watch, created by STAT contributors Ivan Oransky and Adam Marcus, exists solely to shine the spotlight on these retractions. Signal PodcastEpisode 3: Should we believe published scientific research? center_img Meg Tirrell About the Authors Reprints Related: In the world of biotech and pharmaceuticals, investors know the odds are stacked against them. Only about one out of 10 drugs that enters clinical trials ends up as an FDA-approved medicine. Drugs that appear safe in the first few patients begin to appear unsafe after they are taken by a lot of people. Molecules sometimes fail for mysterious reasons.Is science suffering from a reproducibility crisis? How do we really know what we know?Listen to the last episode of the podcast: Two drugs, and the boys’ lives they might saveSubscribe to Signal on iTunes or Stitcher.The Signal podcast is produced by Katie Hiler. @megtirrell Molly Ferguson for STATlast_img read more

A rabid dog made it past border control. Again

first_img Tags CDCrabies Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. “Globally, animal welfare stakeholders should consider focusing their efforts on supporting local organizations that provide adoptive homes, along with health care services, for street animals in their own countries,” they wrote.Scientists in the CDC’s rabies program said the organization isn’t trying to put a stop to such operations or discourage people from adopting companion animals in need of a home. But people who want to adopt an animal could look closer to home, they suggested.“The strong point we’re trying to make here is that there are plenty of adoptable animals here in the United States. About five million animals a year enter a shelter and about half of those will be … put down,” said Ryan Wallace, a veterinary epidemiologist with the CDC. “So there’s no shortage of adoptable animals here in the United States.”Human rabies cases are rareGlobally, nearly 60,000 people a year die from rabies, a virus that attacks the central nervous system. People exposed to the virus will survive, if they are given treatment quickly. But once symptoms start to manifest, the disease is almost invariably fatal. The incubation period — the time from exposure to onset of illness — is typically between three weeks and three months, though it can stretch much longer. Some people only develop rabies a number of years after exposure.In developed countries, human rabies cases are rare. The United States reports one to three cases a year, on average. But rabies remains a public health concern, both because of the fatality rate of cases and the fact that countries like the United States work hard to ensure that the ground gained against the once more-common disease isn’t lost.Before rabies vaccines were developed and mandated for dogs in the United States, there were about 100 rabies deaths a year.The United States spent hundreds of millions of dollars on rabies control programs in the 1950s, ’60s and ’70s to rid itself of canine rabies, Wallace said. The last case of canine rabies — the strain that circulates among dogs — was recorded in 2004. (Other strains of rabies that infect bats, raccoons, skunks, and mongooses are still found in the United States and its protectorates.)Red flags on paperwork“We definitely do not want that canine rabies virus coming back into the United States and being re-established,” Wallace said. “It is the most dangerous [rabies] virus to people. Not that it’s any different in terms of how it impacts us but because it affects dogs, the animals that live in our houses and sometimes sleep in our beds.”Dr. Nicky Cohen said the CDC issued guidelines last year to spell out what is needed, from a rabies control standpoint, to import companion animals to the United States. Chief among them: an authentic rabies vaccination certificate. It also pointed out some red flags to look for on rabies vaccination certificates to spot fakes — things like multiple dogs in a shipment having identical certificates or evidence that a dog’s name has been whited out.“It’s pretty basic,” Cohen admitted. “There have been four incidences where rabid dogs have been imported. But we do know that more dogs than just these four have been imported with falsified records. This was issued in response to the recognition of imported dogs with falsified vaccination records.”The dog from Egypt was part of a shipment of eight dogs and 27 cats. It was the only animal in the shipment that was infected.The animals arrived in New York from Cairo, but were then sent on to New Jersey, Pennsylvania, Maryland, and Virginia — which is where the rabid dog wound up. All had to be traced and checked.Cohen and Wallace said the CDC doesn’t know how many international animal rescue groups are importing animals to the United States, or how many animals a year come in this way. Importations tend to spike when a natural disaster garners a lot of media attention, Cohen noted, such as the earthquake in Haiti in 2010. By Helen Branswell Dec. 17, 2015 Reprints @HelenBranswell About the Author Reprints HealthA rabid dog made it past border control. Again Helen Branswell Ten people who had substantial contact with the animal were advised to get post-exposure rabies treatment and eight more involved in its importation opted to get vaccinated as a precaution, CDC and state health department officials wrote in a report on the incident published in this week’s Morbidity and Mortality Weekly Report, a journal operated by the CDC.‘There’s no shortage of adoptable dogs in the US’The authors said rescue operations that import strays for adoption in the United States might want to rethink their approach to safeguarding the animals’ wellbeing.advertisement A stray dog, one of 10 rescued after being displaced from the Sochi 2014 Winter Olympics, arrives in Washington, D.C., shortly after the games. Chip Somodevilla/Getty Images After a rabid dog made it into the United States from Egypt, rabies experts at the Centers for Disease Control and Prevention are trying to prevent a similar incident from happening again.The rabid dog was transported into the country in May by an animal rescue organization. It was later discovered the dog’s rabies vaccination certificate was a fake, CDC officials said Thursday.It’s the fourth time — that officials know of — in the last 11 years that a rabid dog has been imported to the United States.advertisementlast_img read more

Drug ads don’t prompt most consumers to ask about medicines

first_img Related: Even as a movement grows to limit drug ads aimed at consumers, very few people say advertising prompts them to ask their doctors about the medicines being promoted, according to a survey released on Monday.To be specific, only 7 percent of those queried reported that they made a point of speaking with a doctor about a drug after seeing it advertised on television, according to the survey conducted by Treato, a market research firm. And this was down from 21 percent in a previous survey.Moreover, 76 percent are not inclined to pay attention to an ad just because a celebrity is pitching the medicine; 46 percent want drug ads banned from the Super Bowl; and 80 percent say they are not inclined to pay more attention to animated characters hawking drugs.advertisement By Ed Silverman April 19, 2016 Reprints Tags drug adsdrug marketingFDA @Pharmalot Related: The untold story of TV’s first prescription drug ad Over the past few months, the American Medical Association called for a ban on consumer drug ads, while one congressional lawmaker proposed a three-year moratorium. Another lawmaker wants to end the tax breaks that are given to drug makers for their advertising.As we have noted previously, consumer groups and physicians have argued that ever since the US Food and Drug Administration revised guidelines in 1997 to permit drug makers to use broadcast advertising, some ads too often encourage patients to seek medicines unnecessarily.The AMA — and the lawmakers that proposed the various bills — has also argued that advertising can inflate health care costs if consumers are prompted to seek newer, higher-priced medicines that drug makers may advertise to quickly trigger sales.Impact or no impact, the advertising is being noticed. The survey found that 64 percent of consumers said they felt like they saw more drug ads on TV last year. During the past year, drug ads on TV increased by 26 percent, according to Medical Marketing & Media. PharmalotDrug ads don’t prompt most consumers to ask about medicines [email protected] And some forms of drug advertising rub consumers the wrong way. The survey discovered that 75 percent of the respondents believe that ads for erectile dysfunction pills and low libido drugs should only be shown after 9 pm or not at all.Of course, this is just one survey and the sample size is not all that large, at least in relation to the overall population exposed to TV ads promoting medicines. Nonetheless, the findings do provide a glimpse into consumer thinking at a time when drug makers are pouring more money into ads.Read the most popular stories this hourThe FDA may also want to take note. The agency is conducting a study to determine the extent to which animated characters in TV ads distort consumer understanding of side effect risks. This is the latest in a string of studies that the agency has pursued to gauge the impact of advertising on consumers. About the Author Reprints Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. The FDA wants to know how well older people understand TV drug ads The findings suggest that many consumers may not be easily swayed by the plethora of direct-to-consumer advertising seen on television, a controversial issue that has prompted moves by lawmakers and physicians to restrict this form of promotion.Spending to promote medicines on TV totaled nearly $3.7 billion last year, up 31 percent from 2014, according to Kantar Media. Overall, the pharmaceutical industry spent about $5.4 billion last year on advertising, a 19 percent increase from $4.5 billion the year before.advertisement Benjamin Stone/Flickrlast_img read more

Butter doesn’t increase risk of heart disease after all

first_imgQuick TakeButter doesn’t increase risk of heart disease after all By Lindzi Wessel June 29, 2016 Reprints Please enter a valid email address. Butter, that beloved fatty staple, has been slowly welcomed back into Americans’ diets — and a new study finds it isn’t as bad for our arteries as once believed.Why it matters:Americans are eating more butter than they have in a generation. And the latest diet evidence indicates that saturated fats aren’t as bad for heart health as previously believed. Guidelines shunning saturated fats (found in animal products like red meat and dairy) arose largely out of the 1970 Seven Countries Study, which found that populations consuming high levels of saturated fats had high levels of heart disease. But studies since then have painted a more nuanced picture, with many questioning the demonization of saturated fats.Nowadays scientists are increasingly looking not at broad categories like “saturated fat” but rather at the healthfulness of specific foods, such as butter. But there hasn’t yet been a review of the science focusing specifically on butter.advertisement APStock The nitty gritty:Researchers combined the data from nine studies looking at the relationship of butter consumption with various health outcomes. They found that eating butter didn’t significantly change people’s incidence of cardiovascular disease, coronary heart disease, or stroke. The study did find a small link between butter and overall mortality — each daily tablespoon of butter was linked to a 1 percent increase in mortality risk. On the other hand, the same amount of butter was associated with a 4 percent lower risk of diabetes.“This is neither a health food that should be sought out, and on the other hand it’s not a food that should be avoided at all costs,” said Dr. Dariush Mozaffarian, an epidemiologist at Tufts University and one of the study’s senior authors. The findings were published Wednesday in PLOS ONE.advertisement Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. You should know:Recent studies have found that other dairy foods, including cheese and yogurts, are also associated with decreased risk of diabetes. And specifically, there’s some evidence that some fats in dairy foods are protective.“This study adds to a growing understanding that saturated fats are not public health enemy number one,” said Dr. David Ludwig, an endocrinologist and a professor of nutrition at the Harvard School of Public Health.But keep in mind:Butter consumption tends to correlate with less healthy general lifestyles, and Mozaffarian speculated that this may explain the link between butter consumption and overall mortality.Since most people in the studies only ate a few daily servings of butter, Mozaffarian also emphasized that the findings shouldn’t be extrapolated to very high levels of consumption.The bottom line:Butter has a relatively neutral impact on health, in line with the wider rehabilitation of saturated fats in our diets. Privacy Policy The growing diet divide between rich and poor in America Leave this field empty if you’re human: Related: Tags foodnutritionsaturated fatlast_img read more

Puerto Rico urged to approve aerial spraying as Zika cases pile up

first_imgHealthPuerto Rico urged to approve aerial spraying as Zika cases pile up Tags CDCZika Virus SAN JUAN, Puerto Rico — As many as 50 pregnant women in Puerto Rico are becoming infected with Zika every day, top US health officials said Wednesday as they urged the US territory to strongly consider aerial spraying to prevent further spread of the mosquito-borne virus.The warning came as Puerto Rico debates whether to fumigate with the insecticide Naled, a proposal that has sparked protests in the US territory over concerns about its impact on human health and wildlife.Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, told The Associated Press that aerial spraying is the island’s best defense to fight a virus that can cause microcephaly, a rare defect in which babies are born with abnormally small heads and brain damage.advertisement About the Author Reprints Puerto Rico government officials are still debating the issue, with legislators holding public hearings amid a growing number of protests. Some health officials have warned of the dangers of Naled, with Puerto Rico’s health secretary saying pregnant women and asthmatics should remain indoors if it is sprayed. Puerto Rico has one of the highest asthma rates in the world.Ultimately, it is up to Puerto Rico’s governor to decide whether to implement aerial spraying, which would be run and paid for by the US government.In May, Puerto Rico reported the first microcephaly case acquired on US soil. It involved a fetus that a woman turned over to US health officials who found it tested positive for Zika.A total of 339 pregnant women in Puerto Rico have been diagnosed with Zika, and Frieden said it is only a matter of time before one of them gives birth to a child with microcephaly.Overall, Puerto Rico has reported nearly 2,400 Zika cases, 44 hospitalizations and one death. In addition, 16 people have been diagnosed with a temporary paralysis condition known as Guillain-Barre that has been linked to Zika infections.The CDC estimates more than 20 percent of Puerto Rico’s 3.5 million people could be infected with Zika in an outbreak expected to peak by this summer. Local health officials have dismissed that number as being exaggerated.Frieden said the spread of Zika is not that apparent because eight of 10 people infected show no symptoms and many others have only mild symptoms.“It’s really something of a silent epidemic now,” he said. “The data is extremely clear that it’s spreading rapidly in many parts of Puerto Rico. …This is in line with what we feared would happen.”Gina McCarthy, administrator for the Environmental Protection Agency, told the AP that Puerto Rico needs to seriously consider aerial spraying.“It can be done safely and effectively and is perhaps the most important tool we can use right now to change the trajectory,” she said.The EPA notes on its website that people sensitive to chemicals could experience skin, eye and nose irritation. In addition, it says Naled poses some risk to aquatic invertebrates and wildlife, noting that applications made between dusk and dawn can reduce exposure to honey bees.Frieden said less than two tablespoons of Naled would be used per acre. He said the product was used last year on 6 million acres in Florida, including Miami. He also said it was used in New York and there was no increase in the number of asthma cases there.US officials said aerial spraying would be done several times a week and then weekly, depending on its effect on mosquitoes.“We know how to do this,” McCarthy said. “We are more than willing and anxious to do this.” An Aedes aegypti mosquito is seen through a microscope. Mario Tama/Getty Images By Associated Press July 6, 2016 Reprints He said the island lacks an integrated mosquito control program.“If any part of the continental US had the kind of spread of Zika that Puerto Rico has now, they would have sprayed months ago,” he said. “This is more a question of neglect than anything else. … If we wait until children with microcephaly are born, it will be too late. That’s the problem.”advertisement Associated Presslast_img read more

Government listing of clinical trials doesn’t disclose costs to patients

first_img Tags clinical trialsNIH Patient advocates urge action on clinical trials reporting NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Leave this field empty if you’re human: The company acknowledges that its procedures — like most stem cell treatments — are not FDA-approved. On its website, however, StemGenex underscores that its studies are “registered through The National Institutes of Health which can be found at http://www.clinicaltrials.gov.”“By providing patients access to stem cell studies registered through The National Institutes of Health, patients now have the ability to choose treatment for osteoarthritis that focuses on both safety and efficacy,” it says.Also on its website, the clinic says that having studies registered on ClinicalTrials.gov gives it a “significant advantage compared with treatment centers offering unregistered studies.”Turner called the messages misleading, because they suggest the NIH has vetted the clinic’s osteoarthritis and other studies. “In fact, nobody at the NIH or in our government has necessarily, or even likely, looked at this study,” he said.He pointed to other stem cell clinics posting on ClinicalTrials.gov that ask patients to pay, including one in Rancho Mirage that is conducting a study on stem cell treatment for conditions such as emphysema, osteoarthritis and erectile dysfunction.Knoepfler said he used to direct patients to ClinicalTrials.gov, but then, “I started realizing, ‘wait a minute … there are listings on that website that are not what I thought would be on ClinicalTrials.gov.’”He and other critics would like to see ClinicalTrials.gov reevaluate its position on allowing for-profit trials to post on the website.“It’s one of the best sources we have, but there’s still room for misleading and incomplete information, and I would imagine in some cases, there are people preying on desperate patients, even on the ClinicalTrials.gov registry,” said Ken Getz, an associate professor at Tufts University School of Medicine, and founder of the Center for Information and Study on Clinical Research Participation.This story was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. In clinical trials, for-profit review boards are taking over for hospitals. Should they? Please enter a valid email address. Related: Most Americans would avoid clinical trials due to worries over safety and costs Related: Total charge: $14,000.“I was outraged,” Smith said. Her anger only grew when the screener suggested she could raise the money, as other callers had, through family and friends in an online GoFundMe campaign, she said.advertisement She and others worry that many patients seeking to participate in clinical trials might be desperately sick or in pain, and vulnerable to requests for money they don’t have. These patients see the website’s “.gov” domain and the NIH imprimatur as stamps of approval that mean the research is legitimate, these critics say.“The average patient and even people in health care … kind of let their guard down when they’re in that database. It’s like, ‘If a trial is listed here, it must be OK,’” said Paul Knoepfler, an associate professor at the University of California, Davis, School of Medicine who writes a blog about stem cell research. “Most people don’t realize that creeping into that database are some trials whose main goal is to generate profit.”Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics, said it’s not clear if this phenomenon is only occurring with stem cell studies, but the surge in stem cell research — and in clinics offering high-priced, unproven treatments — has intensified the problem.“It’s not just a handful of patients who are encountering these kind of so-called studies on ClinicalTrials.gov and not just a handful of studies,” he said. “It is a bigger problem than that.”Asked whether costs should be disclosed on ClinicalTrials.gov, Dr. Rebecca Williams, assistant director of the website, said “that’s a valid question.”As a practical matter, she said, “that has been information we don’t collect in a systematic way and nor is it available. We have no way to know whether they’re for-profit or not, and don’t have a policy that would exclude them.”Williams pointed to the website’s disclaimer that the government is not liable for and does not “make any warranties” about information in the database. She also noted that the site suggests questions for consumers to ask, including, “Who will pay for my participation?”Williams stressed that the website is intended primarily as a “clearinghouse” of listings, and that just because a study is there “does not necessarily mean an endorsement by the federal government.”It means that the study sponsors have attested that the information they’re submitting is complete and that their research complies with “all of the applicable regulations that may apply,” she said.The website is not legally required to independently verify the information provided by study sponsors. ClinicalTrials.gov relies heavily on the honor system, Williams said.Study sponsors who wish to list their studies on the website register online and must provide a variety of details, including, in most cases, information about the committees that oversee the welfare and treatment of human subjects.Thanks to a 2007 law, changes will be made to the website’s listings and requirements, possibly by the end of this year. But Williams said it’s “unlikely” they will include disclosures of costs to patients. About the Author Reprints Related: Generally speaking, the US Food and Drug Administration regulates clinical trials of medications and medical devices, and sets guidelines that determine when patients can be charged. But stem cell research, which often uses a patients’ own cells for treatment, can fall into a gray area, and what requires FDA approval is sometimes unclear or in dispute.StemGenex says it does not charge anyone for the osteoporosis study listed in ClinicalTrials.gov.“StemGenex’s study is intended to be an observational study comparing two sets of data — before and after stem cell treatment,” Candace Henderson, the clinic’s vice president of operations, said in a prepared statement.The way she explained it, patients who first pay for the company’s stem cell treatment can then “volunteer” to participate in the long-term observational study of how well the treatment works.“The actual treatment is not part of the study protocol,” Henderson said. She declined to share a copy of the protocol, saying it “is proprietary to StemGenex.”But the reality is that patients who want to participate in research like this must first shell out thousands for the stem cell treatment, University of Minnesota’s Turner said. In effect, he said, they pay to play.StemGenex says it invests revenue from its clinical trials “in innovation and research to further the development and advancement” of therapies. It has four other studies listed on the NIH website: for Parkinson’s disease, multiple sclerosis, rheumatoid arthritis, and chronic obstructive pulmonary disease. In those cases, too, participants “are recruited from among patients who are having stem cell treatment,” Henderson said in the company statement.On its website, the company explains that it harvests dormant stem cells from a patient’s fat through “a mini-liposuction” and isolates the cells from the fat. The cells are then “activated with the patient’s growth factors,” and infused back into the patient. The stem cells then “follow inflammatory signals from damaged tissues and have multiple ways of repairing these damaged areas.”The company, which describes itself as “the premiere leader in the United States for regenerative medicine,” says it offers a “a concierge approach to treatment,” which includes covering the cost of its patients’ hotel accommodations and a car service that “will be waiting for you at the airport baggage claim when you arrive.” Last summer, Linda Smith learned she was losing significant cartilage in her knees, a consequence of her lifelong love of skiing, running, and ultimate frisbee. Diagnosed with osteoarthritis, she wanted to avoid surgery and was eager to consider alternatives.So the 56-year-old Morgan Hill, Calif., resident embarked on a search for clinical trials, which test potential treatments on human subjects. She scoured the government-run website, ClinicalTrials.gov, focusing on a form of stem cell therapy — a promising but unproven approach for her condition.She thought she’d scored with StemGenex, a clinic in La Jolla, and called to inquire. The screener asked a long list of questions, then dropped a bomb: If Smith wanted in, she’d have to pay “associated” costs.advertisement By Emily Bazar — Kaiser Health News July 27, 2016 Reprints HealthGovernment listing of clinical trials doesn’t disclose costs to patients APStock Smith, a retired hospital administrator, knew enough about clinical studies to understand that the $14,000 price tag was unusual. Most trials are free and some even pay people to participate, in recognition of the possible risks and inconvenience involved.The ClinicialTrials.gov website, run by the National Institutes of Health through its National Library of Medicine, is the most comprehensive such database available to the public in the United States, with listings for more than 210,000 clinical studies both here and abroad. But Smith’s experience exposes one of its little-known limitations: It does not require trial sponsors to disclose charges to patients — and does not even independently vet the listings.“I went back to the website and looked at the study again. It doesn’t say that patients are the funding source,” said Smith, who refused the $14,000 proposal. “I was disappointed in the NIH. I thought, ‘Why are you letting this occur?’”StemGenex denies that it charges for participation in its clinical study. It says it only charges for the treatment that is being studied and that participation in the study is separate and voluntary.Some ethicists and other experts who shared Smith’s concern said that’s a false distinction. If trial sponsors require participants to pay, they said, the government website ought to let people know.They argued that ClinicalTrials.gov’s failure to disclose charges by trial sponsors misleads consumers and allows the site to become a marketing tool for pay-to-play research.“It’s unethical that these companies are saying, ‘Sure, come take part in our study and by the way, we’re going to charge you for the privilege,’” said Alison Bateman-House, a postdoctoral fellow in medical ethics at the New York University School of Medicine. “If you’re going to be charging patients for the opportunity to be involved in the study, they should not be allowed to be listed on ClinicalTrials.gov, or at least the cost should be listed on the site.” Privacy Policy Emily Bazar — Kaiser Health Newslast_img read more

Q&A: Abandoning TPP trade deal could spell trouble for biopharma

first_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. About the Author Reprints GET STARTED Tags biotechnologypharmaceuticalspolicypolitics Meghana Keshavan Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED What is it? [email protected] Courtesy McDonnell, Boehnen, Hulbert & Berghoffcenter_img By Meghana Keshavan Jan. 24, 2017 Reprints Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. What’s included? Q&A: Abandoning TPP trade deal could spell trouble for biopharma Pharma As promised, President Trump has promptly abandoned the Trans-Pacific Partnership. What might this mean for biopharma?Nixing the so-called TPP could spell trouble for the biopharmaceutical industry moving forward when it comes to market exclusivity, according to Kevin Noonan, a partner at Chicago-based intellectual property law firm McDonnell Boehnen Hulbert & Berghoff. @megkesh Log In | Learn More last_img read more

EXPLORE: How Yemen’s cholera outbreak spread to a half-million people

first_img Talia Bronshtein/STAT Source: WHO Yemen situation reports 2017 The Yemen case count has been declining since early July, the World Health Organization said Monday, with transmission slowing in previously hard-hit areas. Still, transmission continues in newly affected areas, and it’s estimated 5,000 new people are being infected daily.advertisement By Helen Branswell and Talia Bronshtein Aug. 15, 2017 Reprints The numbers are mind-boggling: Over the past four months, half a million people are suspected of having contracted cholera in Yemen and 2,000 have died from the diarrheal disease.The outbreak took off in earnest in late April, sweeping through this country of 27 million people on the Arabian Peninsula. Yemen has been engulfed in political strife for years, a factor that has greatly exacerbated the scale of this epidemic.Cholera is caused by the bacterium Vibrio cholerae, which attacks the intestine. Most infections are mild, or even symptomless. But as many as 10 percent of infected people develop severe illness — vomiting and profuse, watery diarrhea that lead to a rapid loss of body fluids, which, in turn, can induce dehydration, shock and death.advertisement A Yemeni woman suspected of being infected with cholera receives treatment at a hospital in Sanaa. MOHAMMED HUWAIS/AFP/Getty Images Suspected cholera deaths in Yemen5/22/176/4/176/12/176/17/176/20/176/23/176/26/176/29/177/2/177/5/177/10/177/13/177/16/177/19/177/22/177/25/177/28/177/31/178/6/170500100015002000Number of cholera deathsDateDeaths5/22/173615/27/174715/30/175326/4/176816/7/177946/10/179236/12/179426/13/179746/14/179896/17/171,1006/18/171,1466/19/171,1706/20/171,2056/21/171,2336/22/171,2656/23/171,3106/24/171,3446/25/171,3686/26/171,4006/27/171,4166/28/171,4396/29/171,4756/30/171,5177/1/171,5607/2/171,5877/3/171,6147/4/171,6347/5/171,6577/6/171,6787/7/171,7067/10/171,7327/11/171,7427/12/171,7437/13/171,7597/14/171,7707/15/171,7847/16/171,7907/17/171,8027/18/171,8177/19/171,8287/20/171,8377/21/171,8477/22/171,8587/23/171,8647/24/171,8697/25/171,8807/26/171,8857/27/171,8897/28/171,8927/29/171,8957/30/171,9037/31/171,9158/1/171,9218/3/171,9308/6/171,953Suspected cholera deaths in Yemen HealthEXPLORE: How Yemen’s cholera outbreak spread to a half-million people About the Authors Reprints 5/225/276/46/106/186/257/27/77/167/237/308/658k57k50k49k37k35k32k29k29k27k16k14k14k9k8k5k5k3k2k826496 Talia Bronshtein/STAT Source: WHO Yemen situation reports 2017center_img Talia Bronshtein/STAT Source: WHO Yemen situation reports 2017 The already under-resourced health care system is collapsing under the weight of the outbreak, the WHO said. Millions of people in the country don’t have sources of safe, clean water, and waste collection efforts have ceased in major cities, the agency said.Meanwhile, 30,000 health care workers haven’t been paid for a nearly year — a situation denounced by the new WHO director-general, Tedros Adhanom Ghebreyesus.— Text by Helen Branswell Helen Branswell Yemen cholera outbreak 2017, by governoratePress play or drag the timeline handle to see the number of suspected cholera cases in Yemen. Hover over the map for details.Report dateAug 6 This cholera outbreak is the largest currently underway in the world. Annually, between 3 million and 5 million people are infected with cholera and the infection claims an estimated 100,000 lives every year, according to the Centers for Disease Control and Prevention. @HelenBranswell Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Tags infectious diseasepublic healthlast_img read more

Biotech’s cardio interloper clears a hurdle with sights on Regeneron, Amgen

first_img What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. GET STARTED Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED There’s a small biotech company with big plans to play spoiler in a fight between Amgen and Regeneron Pharmaceuticals, and its cholesterol-lowering pill met its mark in the first of five studies that will determine its fate.Esperion Therapeutics said Wednesday that its once-a-day pill, combined with the now-generic Zetia, lowered bad cholesterol by 28 percent more than the old drug alone, good enough to meet the trial’s primary goal. The study, involving 269 patients, is the smallest and shortest of the five Esperion expects to report this year. The largest, in which 3,000 patients will get either Esperion’s drug or placebo over the course of at least a year, is scheduled to read out in May. Damian Garde By Damian Garde March 7, 2018 Reprints Tags biotechnologySTAT+center_img @damiangarde [email protected] Biotech About the Author Reprints Adobe Log In | Learn More Biotech’s cardio interloper clears a hurdle with sights on Regeneron, Amgen What’s included?last_img read more

Watch: How CRISPR works, explained in two minutes

first_img By Dominic Smith April 4, 2018 Reprints What is CRISPR?Volume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2018/04/04/how-crispr-works-visualized/?jwsource=clCopied EmbedCopiedLive00:0002:1402:14  HealthWatch: How CRISPR works, explained in two minutes Tags CRISPRgenetics Here at STAT, we spend a lot of time trying to imagine — and render — the invisible. We’ve gone inside of a developing embryo. We’ve flown inside our mouths to show the bacterial tribes that take root there. We’ve traveled through time and space to bring back to life a hallowed surgical theater. We’ve followed sound waves through our inner ears into our brains.Of all of these fantastic journeys, one of the hardest subjects to capture, visually, has been CRISPR. Others have tried to capture the essence of the powerful gene-editing technique with the use of analogies.Above, you can find our latest visual attempt to wrangle the genetic complexities of CRISPR into lively, and hopefully enjoyable, two minutes.last_img read more

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